BEUDAMED
    FDA Enforcement Class II Terminated

    Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Medical CFPM 400 Imaging Table OAKWORKS¿ Medical CFPM 401 Imaging Table OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table OAKWORKS¿ Medical CFUR 301 Urology Table OAKWORKS¿ Medical CFUR 401 Urology Table OAKWORKS¿ Medical CFLU 401 Lithotripsy/Urology Table

    Recall: Z-0703-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0703-2018
    Event ID
    79107
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oakworks Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    July 31, 2017
    Classification Date
    February 23, 2018
    Termination Date
    March 29, 2019
    Address
    923 E Wellspring Rd, N/A, New Freedom, PA, 17349-8408, United States

    Description

    Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Medical CFPM 400 Imaging Table OAKWORKS¿ Medical CFPM 401 Imaging Table OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table OAKWORKS¿ Medical CFUR 301 Urology Table OAKWORKS¿ Medical CFUR 401 Urology Table OAKWORKS¿ Medical CFLU 401 Lithotripsy/Urology Table

    Reason

    The foot control used on the OAKWORKS¿ Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table.

    Code Info

    MODEL #(s): "CFPM 300 "CFPM 301 "CFPM 400 "CFPM 401 "CFPMB 301 "CFUR 301 "CFUR 401 "CFLU 401 CATALOG #(s): "75208-T01 and 75209-T01 "75211-T01 and 75212-T01 "75204-T01 and 75205-T01 "75206-T01 and 75207-T01 "75213-T01 "75214-T01 "75215-T01 "75216-T01

    Distribution

    USA (nationwide) Distribution

    Quantity

    1,104